Opportunity Information: Apply for RFA HL 19 005
This National Institutes of Health (NIH) funding opportunity, titled "Management of Asthma in Primary Care - Clinical Center (UG3/UH3 - Clinical Trial Required)" (RFA HL 19 005), is focused on improving how asthma is managed in real-world primary care settings. The central goal is to figure out which asthma management approaches primary care providers are already using, determine which of those approaches appear to work best based on large-scale patient data, and then test the most promising strategies prospectively in clinical trials that are enabled by electronic health records (EHRs). In other words, it is designed to move from observation (what is currently being done and how well it works) to prospective evaluation (testing selected approaches in a structured way), with EHR systems serving as a key tool for identifying patients, measuring outcomes, and supporting trial operations.
The work supported under this announcement is structured around a Cooperative Agreement mechanism, which generally means the NIH expects substantial involvement and collaboration during the project rather than a hands-off grant. The required award structure is a Clinical Center composed of three coordinated parts. First is a Primary Care Network (PCN), which provides access to a broad and representative set of primary care practices and patients with asthma. Second is a Data Management Core (DMC), responsible for the complex data tasks that come with using EHRs at scale, such as assembling data from multiple sites, standardizing variables, ensuring data quality, and supporting analyses and trial reporting. Third is a Clinical Consultation Center (CCC), which supports clinical expertise and consultation needed to interpret asthma care patterns, align proposed interventions with clinical realities, and help design and conduct the prospective EHR-enabled trials. Taken together, these components are intended to create an end-to-end infrastructure: identify existing care patterns in primary care, evaluate them with rigorous analytics, and then run pragmatic clinical trials within the same healthcare environments.
A major emphasis of the announcement is the use of EHR data from a nationally representative sample of patients. This indicates the project is expected to look beyond a single health system or a narrow patient subset and instead capture variation across geography, practice types, and patient demographics. The initial stage involves analyzing EHRs to identify the asthma management strategies currently in use in primary care, such as medication prescribing patterns, follow-up cadence, use of action plans, referrals, and other routine care decisions. From those real-world patterns, investigators are expected to identify paradigms that appear most effective based on outcomes observable in the EHR (for example, asthma control indicators, exacerbations, emergency visits, hospitalizations, or medication use patterns), and then select strategies suitable for prospective testing. The prospective phase is explicitly described as involving EHR-enabled clinical trials, meaning the trials are meant to leverage routine clinical data and workflows rather than operate as isolated research studies divorced from everyday practice.
The award uses the UG3/UH3 phased approach and requires a clinical trial. In practical terms, this type of structure typically reflects an initial phase focused on planning, feasibility, and building the operational and data infrastructure (UG3), followed by an implementation phase where the full prospective evaluation or trial is carried out (UH3), assuming milestones are met. The "Clinical Trial Required" label signals that applicants must be prepared to conduct an actual interventional study rather than only an observational analysis. The overall activity category is Health, and the CFDA number listed is 93.838.
Eligibility is broad across U.S.-based organizations and includes many types of public and private entities. Eligible applicants include state, county, city or township governments, special district governments, and independent school districts, as well as public and state-controlled institutions of higher education and private institutions of higher education. Eligible tribal entities include federally recognized Native American tribal governments and other Native American tribal organizations (including those other than federally recognized tribal governments). The opportunity is also open to nonprofits (both 501(c)(3) and non-501(c)(3) organizations, as long as they are not institutions of higher education in those categories), for-profit organizations (other than small businesses), and small businesses, along with other eligible organization types. The announcement also explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
Foreign participation is specifically restricted. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply. In addition, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by the NIH Grants Policy Statement are not allowed. This means applicants need to ensure the project leadership, core infrastructure, and supported activities are entirely domestic in terms of eligibility and allowable components.
From an administrative standpoint, the opportunity was posted by the NIH, with an original closing date of October 31, 2018, and a creation date of August 2, 2018. The listed funding instrument type is a Cooperative Agreement, and the opportunity category is discretionary. While an award ceiling and expected number of awards are not provided in the supplied text, the program description makes clear that the NIH intended to fund a coordinated Clinical Center capable of running large-scale EHR analyses and pragmatic, EHR-enabled clinical trials focused on asthma management in primary care settings.Apply for RFA HL 19 005
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Management of Asthma in Primary Care - Clinical Center (UG3/UH3 - Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.838.
- This funding opportunity was created on 2018-08-02.
- Applicants must submit their applications by 2018-10-31. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is the title of this NIH funding opportunity?
The opportunity is titled "Management of Asthma in Primary Care - Clinical Center (UG3/UH3 - Clinical Trial Required)" and is identified as RFA HL 19 005.
What is the main goal of this funding opportunity?
The central goal is to improve how asthma is managed in real-world primary care settings by (1) identifying which asthma management approaches primary care providers are already using, (2) determining which approaches appear to work best using large-scale electronic health record (EHR) data, and (3) prospectively testing the most promising strategies in EHR-enabled clinical trials.
What problem area or topic does this opportunity focus on?
The focus is asthma management in primary care, specifically understanding current care patterns and improving outcomes through evidence generated from EHR-based analyses and pragmatic clinical trials.
What does "Management of Asthma in Primary Care" mean in the context of this program?
It refers to routine asthma care decisions made in primary care settings, such as medication prescribing patterns, follow-up cadence, use of action plans, referrals, and other everyday clinical management practices that can be observed and evaluated through EHR data.
Is this opportunity observational, interventional, or both?
Both. It is designed to move from observation (analyzing real-world EHR data to understand existing asthma management strategies and outcomes) to prospective evaluation (testing selected approaches through EHR-enabled clinical trials).
Are clinical trials required under this opportunity?
Yes. The announcement is explicitly labeled "Clinical Trial Required," meaning applicants must be prepared to conduct an interventional study, not only an observational analysis.
What is meant by "EHR-enabled" clinical trials in this program?
EHR-enabled trials are trials that leverage routine clinical systems and workflows. In this opportunity, EHRs are described as key tools for identifying patients, measuring outcomes, and supporting trial operations within real-world primary care environments.
What is the funding mechanism for this opportunity?
The funding instrument is a Cooperative Agreement. This generally indicates substantial NIH involvement and collaboration during the project rather than a hands-off relationship.
What does it mean that this is a Cooperative Agreement?
Based on the description provided, NIH expects substantial involvement and collaboration during the project. The work is not described as purely investigator-driven with minimal interaction; instead, it is structured for coordination and active engagement.
What is the required award structure for the project?
The project must be organized as a Clinical Center composed of three coordinated parts: (1) a Primary Care Network (PCN), (2) a Data Management Core (DMC), and (3) a Clinical Consultation Center (CCC).
What is a Primary Care Network (PCN) in this announcement?
The PCN is the component that provides access to a broad and representative set of primary care practices and patients with asthma, enabling real-world evaluation across diverse settings.
What is the role of the Data Management Core (DMC)?
The DMC is responsible for complex EHR-related data tasks at scale, including assembling data from multiple sites, standardizing variables, ensuring data quality, and supporting analyses and trial reporting.
What is the role of the Clinical Consultation Center (CCC)?
The CCC provides clinical expertise and consultation to interpret asthma care patterns, align proposed interventions with clinical realities, and help design and conduct the prospective EHR-enabled clinical trials.
How do the PCN, DMC, and CCC work together?
Together they form an end-to-end infrastructure: the PCN supplies real-world primary care access and patient populations, the DMC manages and standardizes multi-site EHR data for rigorous evaluation, and the CCC provides clinical guidance to translate findings into practical strategies and support trial design and conduct.
What types of data are emphasized for this project?
The opportunity places major emphasis on EHR data, including use of EHRs to identify patients, capture outcomes, evaluate existing care strategies, and support trial operations.
Is there an expectation about how representative the patient sample should be?
Yes. A major emphasis is the use of EHR data from a nationally representative sample of patients, indicating the project is expected to capture variation across geography, practice types, and patient demographics.
What kinds of asthma management strategies might be evaluated?
Examples described include medication prescribing patterns, follow-up cadence, use of action plans, referrals, and other routine care decisions that occur in primary care and can be observed in EHRs.
What outcomes might be used to judge which strategies appear most effective?
The announcement notes outcomes observable in the EHR, such as asthma control indicators, exacerbations, emergency visits, hospitalizations, or medication use patterns.
What does the UG3/UH3 phased approach mean here?
The UG3/UH3 structure reflects an initial phase focused on planning, feasibility, and building operational and data infrastructure (UG3), followed by an implementation phase where the full prospective evaluation or clinical trial is carried out (UH3), assuming milestones are met.
Is transitioning from UG3 to UH3 automatic?
No. The description indicates the UH3 phase proceeds assuming milestones are met during the UG3 phase.
What is the overall activity category listed for this opportunity?
The overall activity category is Health.
What CFDA number is associated with this opportunity?
The CFDA number listed is 93.838.
Who is eligible to apply for this funding opportunity?
Eligibility is broad across U.S.-based organizations and includes many public and private entity types, such as state, county, city, or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; tribal entities; nonprofits; for-profit organizations (other than small businesses); small businesses; and other eligible organization types described in the announcement.
Are tribal organizations eligible?
Yes. Eligible tribal entities include federally recognized Native American tribal governments and other Native American tribal organizations (including those other than federally recognized tribal governments).
Are nonprofits eligible to apply?
Yes. Nonprofits are eligible, including both 501(c)(3) and non-501(c)(3) organizations, as long as they are not institutions of higher education in those categories.
Are for-profit organizations eligible?
Yes. For-profit organizations are eligible (other than small businesses), and small businesses are also listed as eligible.
Are certain institution types specifically highlighted as eligible?
Yes. The announcement explicitly highlights Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; regional organizations; and U.S. territories or possessions.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are explicitly highlighted as eligible applicants.
Are foreign (non-U.S.) organizations eligible to apply?
No. Non-domestic (non-U.S.) entities, including foreign organizations and foreign institutions, are not eligible to apply.
Can a U.S. organization include a non-domestic component in the project?
No. Non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed.
What does the foreign participation restriction mean in practical terms?
Applicants must ensure project leadership, core infrastructure, and supported activities are entirely domestic in terms of eligibility and allowable components, because foreign entities and foreign components are not allowed under the stated restrictions.
What agency posted this opportunity?
The opportunity was posted by the National Institutes of Health (NIH).
What are the key dates provided for this opportunity?
The creation date is August 2, 2018, and the original closing date is October 31, 2018.
What is the opportunity category?
The opportunity category is discretionary.
Is an award ceiling listed in the information provided?
No. An award ceiling is not provided in the supplied text.
Is the expected number of awards listed?
No. The expected number of awards is not provided in the supplied text.
What type of project capability is NIH looking to fund based on the description?
The description indicates NIH intended to fund a coordinated Clinical Center capable of conducting large-scale EHR analyses and running pragmatic, EHR-enabled clinical trials focused on asthma management in primary care.
Does the announcement suggest the trials should be integrated into everyday practice?
Yes. The prospective phase is described as involving EHR-enabled clinical trials that leverage routine clinical data and workflows rather than operating as isolated research studies divorced from everyday practice.
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